Quality Lead (Product Complaints)

GSK•Zebulon, NC

13h•Hybrid

About The Position

This role will lead the day-to-day quality management of product complaints for a U.S. site. The Quality Lead will manage investigations, drive corrective actions, and ensure complaint handling meets regulatory and company requirements. This position involves close collaboration with colleagues in Quality, Manufacturing, Supply, Regulatory, and Medical Affairs. The company values clear decision-making, practical problem-solving, and a commitment to learning and improvement. This role offers growth, a meaningful impact for patients, and work that aligns with the company's mission of uniting science, technology and talent to get ahead of disease together.

Requirements

Bachelor’s degree in a scientific, engineering, or related discipline, or equivalent experience.
3+ years of quality experience in a pharmaceutical, biologics, or related regulated manufacturing environment.
Direct experience managing product complaints, investigations, CAPA, or similar quality processes.
Experience with complaint tracking systems, quality documentation, and basic data trending.
Solid understanding of Good Manufacturing Practices (GMP) and applicable regulatory expectations in the U.S.
Strong written and verbal communication skills for technical interactions with internal and external stakeholders.

Nice To Haves

Experience approving complaint investigations and acting as final quality reviewer.
Familiarity with complaint-related reporting for periodic product review and regulatory submissions.
Experience supporting regulatory inspections and preparing responses to inspection observations.
Knowledge of risk management, CAPA systems, and root cause analysis tools.
Experience working with cross-functional teams including Medical, Regulatory, and Supply.
Demonstrated ability to drive process improvements and simplify quality workflows.

Responsibilities

Ensure that product complaints are properly received, routed, logged, investigated, responded to, and maintained in compliance with cGMP, FDA, regulatory, and GSK requirements.
Coordinates investigations associated with product complaints.
Participates in investigations to provide the quality views on the root cause and CAPA determinations as needed.
Performs the final approval on the product complaint investigations.
Interact with LOC personnel as needed to contact medical professionals, pharmacists, customers, vendors, and GSK personnel to request answers for technical questions in order to process complaints.
Monitor due dates to assure complete, proper, and timely investigation of product complaints.
Contribute to the development of monthly, semi-annual, and annual reports for product complaint trending, as needed.
Generate complaint data for Periodic Product Reviews, as needed.
Participate in teams to present product complaints during Internal and External Regulatory inspections and prepare responses to deficiency reports, as needed.
Participates in and supports management monitoring, independent business monitoring, corporate audits, and regulatory inspections.
Perform Author and/or Owner responsibilities for Site Compliance documents.